A trial looking at radiotherapy with and without temozolomide for anaplastic glioma (BR14 EORTC 26053-22054)

Cancer type:

Status:

Phase:

This trial compared radiotherapy alone with radiotherapy and temozolomide for a type of brain tumour called anaplastic glioma. This trial was supported by Cancer Research UK.

More about this trial

Anaplastic glioma is a type of brain tumour. Anaplastic means that the cancer cells look less like normal cells than they do in other gliomas. They often grow more quickly than other cancers and can be difficult to treat.

Doctors usually treat brain tumours with surgery and radiotherapy. In this trial they wanted to see if having a chemotherapy drug called temozolomide (Temodal) was a useful treatment for newly diagnosed anaplastic glioma.

There were 4 treatment groups in this trial, they were:

radiotherapy alone

temozolomide and radiotherapy at the same time

temozolomide after radiotherapy

temozolomide both at the same time as and after radiotherapy

Some brain tumour cells have changes in two chromosomes called 1p and 19q. The people taking part in this trial had normal 1p and 19q chromosomes. Doctors call this non co-deleted anaplastic glioma.

The aims of this trial were to find out:

if temozolomide and radiotherapy is better than radiotherapy alone for anaplastic glioma

what the side effects are

Summary of results

The results so far show that temozolomide after radiotherapy could be a useful treatment for people with anaplastic glioma and no changes in chromosomes 1p or 19q.

Results

This trial recruited 745 people with anaplastic glioma. They were put into 1 of 4 treatment groups at random, and:

187 people had radiotherapy (group 1)

185 people had radiotherapy and temozolomide at the same time (group 2)

185 people had radiotherapy and then temozolomide (group 3)

188 people had radiotherapy and temozolomide at the same time, and then more temozolomide (group 4)

So far, the research team have compared people who didn’t have temozolomide after radiotherapy (groups 1 and 2) with people who did (groups 3 and 4).

They have looked the number of people whose glioma had not started to grow 5 years after treatment. They found it was:

More than 2 out of 10 people (24%) who didn’t have temozolomide after radiotherapy

More than 4 out of 10 people (43%) who did have temozolomide after radiotherapy

They also looked at the number of people living 5 years after treatment, and found it was:

More than 4 out of 10 people (44%) who didn’t have temozolomide after radiotherapy

More than 5 out of 10 people (56%) who did have temozolomide after radiotherapy

Side effects

When they looked the side effects of temozolomide, they found that many of the side effects were mild or short lived. Between 8 and 12 out of every 100 people (8 – 12%) had more serious side effects. The most common was a drop in cells which help blood to clot (platelets).

Future results

Some of the people taking part in this trial are still having treatment and follow up appointments. The information here is for the results so far (called interim results). The research team plan to publish more results when the trial ends. This will include results for the group having radiotherapy and temozolomide at the same time. We plan to update this page once these results are available.

Conclusion

The research team concluded that, so far, the results show that temozolomide after radiotherapy is a useful treatment for newly diagnosed, non co-deleted anaplastic glioma. They suggest that it should be considered as part of standard treatment for this group of patients.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

04/12/2007

Recruitment end:

19/09/2015

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Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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